Last reviewed 2026-05-23 · How we verify

Liposomal Alendronate

BIOrest Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

Liposomal Alendronate is a Small molecule drug developed by BIOrest Ltd.. It is currently in Phase 2 development. Also known as: LA.

Liposomal Alendronate is a small molecule inhibitor of farnesyl diphosphate synthase, a target involved in the synthesis of farnesyl pyrophosphate. It is being studied in clinical trials for conditions such as diabetes mellitus and coronary artery stenosis.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Liposomal Alendronate
Also known as	LA
Sponsor	BIOrest Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Liposomal Alendronate CI brief — competitive landscape report
Liposomal Alendronate updates RSS · CI watch RSS
BIOrest Ltd. portfolio CI

Frequently asked questions about Liposomal Alendronate

What is Liposomal Alendronate?

Liposomal Alendronate is a Small molecule drug developed by BIOrest Ltd..

Who makes Liposomal Alendronate?

Liposomal Alendronate is developed by BIOrest Ltd. (see full BIOrest Ltd. pipeline at /company/biorest-ltd).

Is Liposomal Alendronate also known as anything else?

Liposomal Alendronate is also known as LA.

What development phase is Liposomal Alendronate in?

Liposomal Alendronate is in Phase 2.

Manufacturer: BIOrest Ltd. — full pipeline
Also known as: LA

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing